A major initiative that will provide generic antiretroviral HIV/AIDS drugs
in the poorest nations has been announced today by The Clinton Foundation,
The World Bank, UNICEF and the Global Fund. The announcement substantively
snubs the attempts last week to sideswipe the generic drug industry by
impugning the WHO's widely accepted drug quality standards. The Clinton
drugs will treat at least four times as many patients for the same price.

"The historic Clinton Foundation drug pricing and distribution deal is a
powerful slap to President Bush's arrogant attempts to limit the use of
generic AIDS medicines to suit the whims of his pharmaceutical backers.
Clinton has thrown a spanner in the works, slowing the Bush Administration's
shameful efforts to use their AIDS relief program to create a slush fund for
big pharma," said Paul Davis from Health GAP. "The Clinton approach
represents the direction Bush Administration policy should take, if the
White is serious about fighting AIDS." Activists note that the Kerry
campaign has opposed limitations on the use of affordable generic AIDS
drugs for developing countries. (www.johnkerry.com/issues/aids/)

In Congressional testimony and and at a two-day meeting in Botswana last
week, Bush officials sought to undermine and discredit the quality of the
drugs that Clinton Foundation, the Global Fund and others will now negotiate
and finance. The meeting was extremely contentious, with Health GAP and
other NGOs joining governments and UN Agencies to stand by WHO's drug
quality standards. No consensus was reached at the meeting, in spite of
Administration pressure to settle.

The State Department is insisting the U.S. FDA or a similar wealthy country
drug regulatory authority perform new assessments of the safety and efficacy
of generic medicines, rejecting the WHO's internationally supported pre-
qualification program which assures the quality and safety of medications.
The protocol of the WHO program mimic FDA standards, however, patent
barriers prohibit the approval of generic AIDS drugs by the agencies deemed
acceptable to Bush officials -- an intentional Catch-22. The WHO has
approved dozens of generic AIDS medications for use by numerous national
governments, UNICEF, the World Bank, the Global Fund to Fight AIDS, TB, and
Malaria, and groups such as Médecins Sans Frontières (MSF).

The Clinton Foundation will negotiate the prices for fixed-dosed
combinations (FDCs) of antiretroviral medications, drugs current White
House officials have been particularly opposed to. The use of FDCs, which
combine drugs from multiple originators into single pills, promote
adherence, decrease the risk of resistance and facilitate efficient
stock and procurement management.

WHO recommended FDCs now available are one pill, taken twice daily. FDCs are
the least expensive option: a generic triple combination costs less than
$140 per person per year. In the developing world, the same combination from
brand-name companies costs a minimum of $562 per person per year and must be
taken in the form of six pills a day.
"President Bush is a puppet of the drug companies," said Health GAP's Staci
Smith. "His plan is to force millions of people with HIV/AIDS to accept
higher pill burdens and waste tax money to line the pockets of big pharma."
By denying quality assured generics under it bilateral initiative, and by
requiring poor countries to establish parallel systems for affordable
generics, the White House will have raise significant new barriers that
lock developing countries into to using only branded drugs.
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